Laparoscopic Training With Laser Guidance Trial

Not Applicable

Completed

• Conditions: Depth Perception
• Interventions: Device: Laser Visual Guidance; Device: 2 D vision

• Registration Number: NCT02407483
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

"Laparoscopic simulation training with or without laser visual guidance -A randomised study" which investigates if the use of laser visual guidance can help the novices to learn the laparoscopic skills.

Detailed Description

Background: The loss of depth perception due to working in a three-dimensional space based on two-dimensional images is one of the challenging aspects of laparoscopy compared to conventional open surgery.

Objectives: To examine the effect of laser visual guidance on laparoscopic performance and cognitive load in a simulated setting for novices.

Methods: Randomised Clinical Trial- Laser visual guidance vs. normal 2 D vision.

Outcomes:

Primary outcome: Motor skills performance parameters-movement-time:

Cumulative instrument movement-time for both the right and left instrument for the test session,

Secondary outcome: 2) The overall composite score.

Exploratory outcomes: 3) The NASA Task Load index (NASA-TLX).

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Surgical novices / medical students enrolled at The Faculty of Health Science, University of Copenhagen.
• Participants are required to provide informed consent before inclusion.

Exclusion Criteria

• Participation in prior studies involving laparoscopic training.
• Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
• No informed consent.
• Does not speak Danish on a conversational level.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Visual Guidance group	Laser Visual Guidance	Will be tested using simulated laparoscopic tasks with the use of laser visual guidance
Normal 2D vision group	2 D vision	Will be tested using simulated laparoscopic tasks without the use of laser visual guidance

Primary Outcome Measures

Name	Time	Method
Motor skills performance parameters (Cumulative Instrument movement-time)	3 hours	Cumulative Instrument movement-time

Secondary Outcome Measures

Name	Time	Method
The composite performance score (errors)	3 hours	points

Trial Locations

Locations (1)

Centre for Clinical Education; 🇩🇰 Copenhagen, Cooenhagen Ø, Denmark